Local physician shares antibody testing results

Dr. Gail King takes blood from Marshall Crouch in Aspen on Friday, April 10, 2020.Kelsey Brunner/The Aspen Times

In January, February and early March, Dr. Gail King and her medical staff saw a lot of people who said they were very sick.

An Aspen-based gynecologist, anti-aging and regenerative medicine physician who owns the Aspen Center for Women’s Health and REGEN Aspen, King said many of the people coming in for check ups, treatments or other medical reasons also described having upper respiratory symptoms that seemed to last longer than usual. It was before King or her colleagues had really even considered the novel coronavirus as a potential cause, she said.

But when the first COVID-19 case was linked to Aspen on March 8 after an Australian visitor tested positive for the disease upon returning home, King began to wonder if the sickness described to her over the previous two months had really been COVID-19 — and if she and her staff had been exposed to it.

“We needed to know if any of us had been infected and there was no other testing being done,” King said earlier this week. “Once I found (an accurate antibody) test and we ordered it for my office and we tested all of us, I said to myself, ‘Well gosh, if I want to know I wonder if other people want to know, too.’”

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Over the past four weeks, King has opened up testing to Aspen-area residents interested in knowing if they have COVID-19 antibodies, which the human body produces to fight pathogens like the novel coronavirus. Antibodies continue to be produced after a person has recovered from an illness and can create a certain level of immunity to future infections from the same virus.

Residents interested in being tested for COVID-19 antibodies and able to pay $350 for the blood-draw test have ordered kits through King from a Massachusetts-based diagnostics company. King asked people getting tested to fill out a questionnaire focused on when they were sick and what symptoms they experienced.

In the first two weeks of testing, starting April 6, King said she and her staff tested 198 people with 7.6% of the tests coming back positive for COVID-19 antibodies. This includes her staff’s test results.

Over the third week of testing, King said 54 people were tested with 18.5% of the tests coming back positive for antibodies, averaging out to a 9.9% positivity rate over the three-week time period and more than 80% of the 25 people who tested positive saying they were sick in March.

“My speculation is the vast majority of people who have tested positive were sick in March, not January and February like I first speculated based on hearing so many people say they were sick then,” King said, noting that she was surprised by the results and thinks some other sickness spread through Aspen in early 2020.

“So what we’re seeing is that with the people who were sick in March, which was almost everybody who tested positive, it’s just been long enough now for most of them to develop their antibodies.”

ANTIBODY TESTING DEBATE

Although King feels the information she’s collected is valuable in understanding how the novel coronavirus has spread through the Aspen area and if people are potentially developing some immunity, she said she knows it is only one piece of the data needed to truly see the community impact of COVID-19 and that it hasn’t affected how she’s advising people to behave during the pandemic.

King said all she can confidentially tell people based on their test results is that they had COVID-19, did not have COVID-19 or haven’t developed longterm, rapid-response protection antibodies yet, and that they should still practice good hygiene, social distancing and wear a mask in public no matter what their results were.

“Regardless of whether your antibody test was negative or positive, it doesn’t change behavior right now,” King said. “What my data shows is: yes, (COVID-19) was here; yes, people were infected; and yes, people are developing antibodies.”

In the past few weeks, antibody testing, its effectiveness and the role it should play in both understanding and responding to the COVID-19 pandemic has become a hot topic of conversation.

Some international governments and U.S. officials have looked at widespread antibody testing as a way to determine immunity to COVID-19 and reopen communities quicker, some even suggesting “immunity passports” or “risk-free certificates” be given to people who test positive for antibodies so they can travel or return to work.

Leading virologists, epidemiologists and trusted public health entities including the World Health Organization support antibody testing as a way to better understand how the novel coronavirus spreads, along with the extent of and risk factors associated with infection. However, as of April 24, no study has evaluated whether the presence of COVID-19 antibodies confers immunity to future infection by the novel coronavirus, according to the WHO, and current COVID-19 antibody tests need further validation to determine their accuracy and reliability.

In the United States specifically, recent research reported in news publications like The New York Times suggest that many COVID-19 antibody tests being utilized across the country are often inconsistent or inaccurate with a high rate of false positives, do not signify immunity to virus infection and should not be relied upon for policy decision making.

But for medical experts like Brent Dorval — founder and chief scientific officer for KBMO Diagnostics, the company King ordered her COVID-19 antibody tests from — this doesn’t mean all antibody tests are bad and that the country should stop utilizing them altogether.

Dorval holds a Ph.D. in microbiology and immunology and has spent the majority of his career researching viruses. He helped develop the first HIV/AIDS diagnostic assay about 25 years ago and was a former adviser to the WHO’s committee on vaccines and diagnostics.

In early April, Dorval said KBMO Diagnostics started working with a Chinese company that had developed a sensitive, specific COVID-19 antibody test.

After carefully vetting the test, Dorval said the KBMO team determined it was “darn good” with an overall sensitivity of 87.5%, referring to the test’s ability to correctly identify people with COVID-19 antibodies; and 100% specificity, referring to the ability of the test to correctly identify people without the antibodies.

KBMO partnered with the Chinese company and started the process of distributing tests, taking them back for analysis and then reporting the results.

“Antibody testing is pretty much getting a bad rap these days … but this is quite a good test in that we found it is sensitive and specific, the reads are clean and the results overall are very, very good,” Dorval told The Aspen Times on Monday.

Over the month of April, Dorval said the KBMO Diagnostics lab has processed results for 4,000 to 5,000 antibody tests. In Colorado specifically, Dorval said KBMO has evaluated 426 tests with 7.5% testing positive for COVID-19.

For Dorval, he sees the opportunity to distribute and process good, high-quality COVID-19 antibody testing as a public service and important piece to understanding the novel coronavirus, which is why he said he came out of retirement to do it.

“I’m almost 67 years old and I retired two years ago but I came back to work with this company because I think this is a good product,” he said. “I think there’s a need and I hope I can help provide some good public service.”

TESTING’S ROLE IN COUNTY REOPENING

When asked what role he sees COVID-19 testing playing in how public health officials respond to and mitigate the spread of coronavirus, Dorval said he feels it would be most useful to combine PCR testing — which determines if a person is actively sick with COVID-19 — with antibody testing to better detect who has or has had the novel coronavirus disease and how it is spreading.

While some places in the U.S. are able to do both, many like Pitkin County have recently chosen to focus on community-wide PCR testing only, as some U.S. health experts say this diagnostic testing offers a “better snapshot of the current picture” with timely data on the rise or fall in infection numbers when accurate, as reported by The New York Times.

“We’re really excited about the expanded ability of the PCR testing, the nasal swab tests which really detect an active infection and is really what’s key for us being able to move forward with rigorous contact tracing,” Pitkin County Manager Jon Peacock said Tuesday.

“That’s how you get a strategy where you’re really dealing with individuals where they are with a potential infection versus these broad, public health orders which really require everyone to have limited social and economic interactions.”

The tests are being processed at a handful of different labs based on favorable turnaround times, including the Colorado State Laboratory, and have a 25% to 30% potential for false negative results, according to Jennifer Slaughter, chief marketing officer for AVH. As of end of day Tuesday, 25 people had been tested.

Pitkin County also has 1,000 antibody tests acquired from Aytu Bioscience of Englewood, but has moved to shelve them for now, as public health officials are concerned with the accuracy of the tests and the fact that they are not FDA approved.

“You don’t take the next steps without having some data to understand what’s happening with infection rates,” Peacock said.

“That’s one of the reasons why it was important to be able to provide testing for all symptomatic people as well as have this enhanced contact tracing capability. … We will continue to look at these metrics and this will not be a reopening all at once.”

However, King said while Pitkin County knows about the antibody testing she’s conducted, she has no formal way of reporting the results locally. King does plan to submit her results to the state and is still doing some on-demand antibody testing this week, as she believes there is still a need for it.

But while King said it’s good there is community-wide PCR testing in Pitkin County, she feels that a lot of critical data on the novel coronavirus and its local spread in March is lost for good, noting that efforts now may be “too little, too late.”

“I think we should have been testing more people earlier, even if it was rationed,” King said, referring to the nationwide testing shortage that drove states like Colorado and counties like Pitkin with limited capacity to restrict which symptomatic people were tested in March and much of April.

“Would it have changed anything? I don’t know. But I can tell you my data would make more sense if everyone who took my antibody test had a nasal swab and we knew who was truly positive and truly negative (for COVID-19).”

She continued, “I welcome anyone from the county health department or academia or an epidemiologist to sit down with me. I’m not hiding this information,” King said. “I do think there’s value in it for this community.”

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